MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; HARMONIC ACE

Model Number	420275-03
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the harmonic ace instrument had a product breakage.A backup instrument of the same kind was used to complete the procedure with no patient harm.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: before use, the staff had checked the accessories and equipment.No debris fell into the patient's body during the procedure.The relevant accessories were new, the surgeon has extensive experience, and there is no improper operation during use.The removal process was smooth, and broken instrument can be returned.The harmonic ace instrument involved in this reported event has been received for failure analysis testing.However, as of the date of this report, the investigation is still in progress.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The harmonic ace instrument was analyzed and the instrument failed to rotate during manual articulation.The instrument was found to have corrosion on the gear, helical roll input assembly.The debris in the gears prevents operation.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: HARMONIC ACE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19925731
• Report Number: 2955842-2024-17889
• Device Sequence Number: 2725380
• Product Code: NAY
• UDI-Device Identifier: 00886874111765
• UDI-Public: (01)00886874111765(10)K10230818
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420275-03
• Device Catalogue Number: 420275
• Device Lot Number: K10230818 613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 10/02/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/06/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Prefer Not To Disclose